SFS — Revumenib Eligibility Detection System Class II
FDA product code SFS covers "Revumenib Eligibility Detection System", a Class II medical device regulated under 21 CFR 864.1885. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFS
- Device Class
- Class II
- Regulation Number
- 864.1885
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
A revumenib eligibility detection system is identified as a prescription in vitro diagnostic device intended for the qualitative detection of structural abnormalities of chromosome 11 in specimens from patients with acute leukemia for the purpose of identifying patients who may benefit from treatment with revumenib, in accordance with the approved therapeutic product labeling.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240067 | cytocell limited | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | September 19, 2025 |